Evidence map›Paper›PMID 34815721›Full record

ArticleMedical devices (Auckland, N.Z.)2021

Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.

Jakob Lange, Andreas Schneider, Christoph Jordi, Michael Lau, Timothy Disher

Open access · goldAbstract read
In one paragraph

Article in Medical devices (Auckland, N.Z.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Jakob LangeYpsomed Delivery Systems, Ypsomed AG, Burgdorf, Switzerland.ORCID 0000-0002-3018-8265
Andreas SchneiderYpsomed Delivery Systems, Ypsomed AG, Burgdorf, Switzerland.
Christoph JordiYpsomed Delivery Systems, Ypsomed AG, Burgdorf, Switzerland.
Michael LauInsight Product Development, Chicago, IL, USA.
Timothy DisherInsight Product Development, Chicago, IL, USA.
Ypsomed (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe subcutaneous self-administration of biologics using a single large-volume bolus dose requires novel large-volume patch injectors. However, the usability and wearability of such on-body devices has rarely been investigated thus far. Therefore, this formative simulated use experiment studies the overall handling and acceptability in terms of the size and weight of a novel 10 mL large-volume patch injector device platform.

methodsTwenty-three participants, including patients and healthcare professionals, simulated two injections with the large-volume patch injector, each lasting 17 min. During the injections, the patient participants performed predefined movements and activities with the on-body devices. Perceived usability and wearability were assessed through observation by the moderator and participant-reported feedback using five-point Likert scales and open-ended interviews.

resultsAll participants successfully completed the simulated injections. Only non-serious usability issues were identified. Users rated the device acceptability in terms of wearability and usability with high ratings.

conclusionThe results suggest the safe and effective usage of a novel prefilled large-volume patch injector that enables the subcutaneous delivery of a single bolus dose of up to 10 mL with an injection duration of 15 min. The participants of the simulated use study successfully used the device regardless of the disease state, age, or body size and habitus.

Indexed as

bolus dosedrug deliverylarge-volume injectionmedical devicesself-medicationsubcutaneous injectionusability

Identifiers

PMID34815721
PMCPMC8605886
OpenAlexW3212883890

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.